Local Study Associate Director – Oncology
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Job Description
Local Study Associate Director managing clinical trials and Local Study Teams for Parexel in Canada. Responsible for site management, study commitments, and ensuring compliance with regulations.
Responsibilities:
- Leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
- Ensures that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Organizes regular Local Study Team meetings on an agenda driven basis.
- Proactively identifies risks and facilitates resolution of complex study problems and issues.
Requirements:
- Minimum 3 years of experience in Development Operations leading clinical trials end to end in Canada in a CRO or Pharma organization.
- Direct experience in Oncology clinical trial management.
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
Benefits:
- Ability to travel nationally and internationally as required
- Integrity and high ethical standards
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